Events

Rappel de Device Recall ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Arrow International Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    77589
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0182-2018
  • Date de mise en oeuvre de l'événement
    2017-06-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156673
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Cause
    There is a possibility that the finished good kits may contain 5 fr peel-away sheaths instead of the required 4 fr peel-away sheaths.
  • Action
    Arrow International sent an Urgent Medical Device Recall Notification letter dated June 1, 2017, and Recall Acknowledgement Form to their domestic consignees via FedEx 2-day. Customers were advised to immediately inspect stock, discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the firm to document the amount of product you have on hand for return. A customer service representative will the customer with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the company to document your receipt of the letter. Customers that have any questions can contact their local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC)
  • Modèle / numéro de série
    Lot/Batch Number: 23F16L0021
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
  • Description du dispositif
    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) || The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA